33808_LME-10_2011_ENG

2. Signed for and on behalf of Franz Mensch GmbH, Buchloe, 13.10.2021 Amanda Kreuzmann Head of Quality Management Updated 13.10.2021 Page 2 / 2 F ranz Mensch GmbH F ranz Mensch GmbH Werner-von-Siemens-Str. 2 86807 Buchloe, Germany phone: +49 8241 9633-0 phone: +49 8241 9633-0 fax: +49 8241 9633-100 fax: +49 8241 9633-100 internet: www.franz-mensch.de e-mail: verkauf@franz-mensch.de Franz Mensch is a ISO certified company DIN EN ISO 9001:2015 DIN EN ISO 9001:2015

1. Declaration of Conformity Declaration of Conformity For plastic materials coming into contact with food For plastic materials coming into contact with food The manufacturer: Franz Mensch GmbH Franz Mensch GmbH Werner-von-Siemens-Str. 2 Werner-von-Siemens-Str. 2 D - 86807 Buchloe D - 86807 Buchloe herewith declares that the following delivered item Item REF Item REF 33808 33808 Description Description Glove tightener Glove tightener Brand Brand Hygostar Hygostar Version Version Colour: White Colour: White Size: Onesize Size: Onesize complies with the legal requirements of the current valid version of the Regulation (EU) No. 10/2011, as well as of the Regulation (EU) No. 2023/2006 and of the Regulation (EC) No. 1935/2004. If used according to specifications, both the overall migration and the specific migration levels remain below the legal limit according to Regulation (EU) No. 10/2011. The substances and raw materials used are in compliance with Regulation (EU) No. 10/2011. Proved that the products contain substances with limitations (SML/QM) as well as Dual-Use-Substances, the limits provided in Regulation (EU) No. 10/2011 are complied. For substances that are not mentioned in the union list (Annex I of Regulation (EU) No. 10/2011 including all amendments of the Regulation (EU) NO. 2019/37), national instructions shall apply, as e.g. the German BfR Recommendations on Food Contact Materials. Overall Migration Food simulant Food simulant Overall Migration Overall Migration Migration Limit Migration Limit Ratio Ratio acetic acid 3% <10 10 mg/dm² ethanol 10% <10 10 mg/dm² vegetable oil 3,5 10 mg/dm² Specification for intended use or restrictions: Ratio of the surfaces coming into contact with the food to the volume, on the basis of which the conformity of the material has been determined: 6dm²/kg 6dm²/kg Type/types of food that shall come into contact with the material: acidic, greasy, watery, alcoholic acidic, greasy, watery, alcoholic Type/types of food that shall NOT come into contact with the material: none none Duration and temperature of handling and storage when in contact with the food: Simulanz Simulanz Duration Duration Temperature Temperature acetic acid 3% 2 Std 40° C ethanol 10% 2 Std 40° C vegetable oil 2 Std 40° C The traceability of the product is ensured according to Regulation (EC) No. 1935/2004, article 17, by the information of date of production and LOT-number on the marking of the product. Updated 13.10.2021 Page 1 / 2 F ranz Mensch GmbH F ranz Mensch GmbH Werner-von-Siemens-Str. 2 86807 Buchloe, Germany phone: +49 8241 9633-0 phone: +49 8241 9633-0 fax: +49 8241 9633-100 fax: +49 8241 9633-100 internet: www.franz-mensch.de e-mail: verkauf@franz-mensch.de Franz Mensch is a ISO certified company DIN EN ISO 9001:2015 DIN EN ISO 9001:2015